NCT05255601 · OUTCOME
Number of Participants With Serious Adverse Events (SAEs) - Part A
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- from first dose to 135 days post last dose (Up to approximately 11 months)
What was measured
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Analysis population: All treated participants in part A
Groups in this outcome
Part A - Flat Dosing (AF)
Participants received treatment with Relatlimab 160 mg + Nivolumab 480 mg Q4W
Part A - Age/Weight-based Dosing (AW)
Participant received treatment with Relatlimab 2 mg/kg + Nivolumab 6 mg/kg Q4W
| Group | Source count |
|---|---|
| Part A - Flat Dosing (AF) | 4 |
| Part A - Age/Weight-based Dosing (AW) | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - Flat Dosing (AF) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A - Age/Weight-based Dosing (AW) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
- groups
- description
- Participants received treatment with Relatlimab 160 mg + Nivolumab 480 mg Q4W
- id
- OG000
- title
- Part A - Flat Dosing (AF)
- description
- Participant received treatment with Relatlimab 2 mg/kg + Nivolumab 6 mg/kg Q4W
- id
- OG001
- title
- Part A - Age/Weight-based Dosing (AW)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants in part A
- reporting Status
- POSTED
- time Frame
- from first dose to 135 days post last dose (Up to approximately 11 months)
- title
- Number of Participants With Serious Adverse Events (SAEs) - Part A
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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